Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00767520
Eligibility Criteria:
Inclusion Criteria:
* Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis
* Prior therapy with a non-steroidal aromatase inhibitor
* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)
* Documented breast cancer with tumor ≤ 28 days prior to study entry
* Women who are NOT of childbearing potential
* Must be able to take oral medication
* Performance Status 0 or 1
Exclusion Criteria:
* Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry
* Any chemotherapy, immunotherapy \< 6 months before study entry. Any targeted therapy (eg. lapatinib) \< 6 months before study entry, unless given in combination with an NSAI
* Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry
* Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer
* Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years
* Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding
* Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval \> 450 msec at baseline (Fridericia correction)
* Hematologic abnormality Grade ≥ 2
* Hypocalcemia of Grade ≥ 1
* Any Chemistry abnormality of Grade ≥ 2 \[except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease\]
* Pregnant Women and Women of Childbearing Potential (WOCBP)
* Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)
* Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)
* Potent inhibitors of CYP3A4 isoenzyme
* Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00767520
Study Brief:
Protocol Section:
NCT00767520